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The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Read More
The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate testing and poor quality controls. Read More
Japanese drugmaker Daito Kasei Kogyo was hit with a warning letter by the FDA for having inadequate testing procedures and falsifying certificates of analysis issued to customers from its facility in Bizen, Okayama. Read More